# Core C - Clinical Trials

> **NIH NIH P01** · UNIVERSITY OF IOWA · 2021 · $176,102

## Abstract

Project Summary/Abstract - Core C:
Core C will provide experienced, well-trained clinical trials staff specializing in implementing translational,
clinical research involving pharmacological ascorbate (P-AscH-). This group of clinical researchers has been
doing clinical trials for the past 10 years and has initiated as well as completed phase 1 and 2 trials using
P-AscH- combined with radiation and/or chemotherapy in pancreas, lung, and GBM subjects. Core C will
initiate, conduct, and complete all aspects of complex human subjects research with P-AscH- which are
proposed in Projects 1 and 2. Core C will also interface with Core B for patient sample acquisition and
processing, for biomarker evaluation as well as establishing a structured training program for staff participating
in each clinical trial research effort. This training program will include instruction in how to review processes for
eligibility determination as well as the review of ascorbate therapy infusions (including administration, review of
and contraindications) and adverse event reporting. In addition, Core C will provide expert guidance and
resources as well as interface with the Holden Comprehensive Cancer Center clinical trials infrastructure [(i.e.,
Protocol Review & Monitoring Committee (PRMC)/ Data and Safety Monitoring Committee (DSMC)] to identify
and report all key research data, and to design electronic case report forms for complete data capture, and to
ensure data veracity for ultimate result reporting to the FDA, and as well as in the preparation of peer-
reviewed publications.

## Key facts

- **NIH application ID:** 10240535
- **Project number:** 5P01CA217797-04
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** John M Buatti
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $176,102
- **Award type:** 5
- **Project period:** 2018-09-19 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10240535

## Citation

> US National Institutes of Health, RePORTER application 10240535, Core C - Clinical Trials (5P01CA217797-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10240535. Licensed CC0.

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